A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Occurrence of major complications during 6 months after creos xenoprotect placement
研究概览
简要总结
The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane.
The primary endpoint of the study is the occurrence of major complications during 6 months after creos xenoprotect placement whereas the hypothesis is that these major complications occur in less than 5% within this timeframe.
This is a retrospective, multicenter clinical investigation with consecutive cases. Data will be collected on consecutive data cases from patient files, given that these patients were treated within a defined indication with creos xenoprotect in the past. Patients participating in this study do not have any obligations or need to come back for any intervention. A total of 11 centers are planned to be included. Sample size is n=200 patients and is distributed equally in four indication groups:
Group 1: Ridge augmentation (vertical and horizontal) Group 2: Alveolar ridge preservation Group 3: Sinus floor augmentation Group 4: Augmentation around implant or teeth
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant was treated before December 2023 (creos xenoprotect placement)
- •Participant signed informed consent form and data protection consent form1
- •Participant was at least 18 years old at the time of treatment
- •Participant received guided bone regeneration combined with the use of creos xenoprotect according to one of the four indications
- •Participant was treated according to instructions for use (IFU)
- •Participant should have follow-up time of >9 months after placement of the investigational device
排除标准
- •In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane
结局指标
主要结局
Occurrence of major complications during 6 months after creos xenoprotect placement
时间窗: From Surgery to 6 Months Follow-Up
次要结局
- Occurence of minor complications (dehiscence, membrane exposure, infection) during 6 months after placement of creos xenoprotect(From Surgery to 6 Months Follow-Up)
- Number of cases with successful bone graft: o Implants: sufficient bone at implant insertion visit o No implants: additional bone grafting intervention needed at 6 Months Follow-Up(From Surgery to 6 Months Follow-Up)
- Clinician satisfaction / handling with creos xenoprotect at Membrane Placement (VAS Scale)(At Surgery)
- SAE, SADE, USADE, DD(From Surgery to 9 Months Follow-Up)